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Breast Neoplasms clinical trials

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NCT ID: NCT02276885 Active, not recruiting - Breast Cancer Clinical Trials

Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial

Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days

NCT ID: NCT02266420 Active, not recruiting - Clinical trials for Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm

Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm

COCABIO000
Start date: October 23, 2014
Phase: N/A
Study type: Interventional

This is a prospective, non-randomized and multicenter study designed to compare biological features between pN0 triple negative breast cancer (TNBC) with size ≤ 10 mm (pT1a/b) versus pT1c T2 ≤ 30 mm. All consecutive patients will be recruited by each investigator after completion of surgery. No modification of standard management according to each investigator center will be done. All patients will then be followed each year during 5 years in order to collect the following events: local and loco regional recurrence, metastatasis, second cancer, death or not and the cause. At initial visit, a 10 mL blood sample will be collected (= study intervention) and immediately processed for serum storage; all serum samples will be stored at -80°C and may be used for the purpose of further scientific research. A representative formalin-fixed paraffin-embedded tumor block of all 200 samples will be addressed at the Institut Claudius Regaud for central collection which will consist of one haematoxylin-eosin stained slide for central histological review, up to 15 unstained slides for DNA extraction (after microdissection), and construction of a tissue micro-array (TMA). Extracted DNA from 100 samples (50 in each group) will then be transferred to Institut Paoli Calmettes, Marseille; extracted DNA will be subjected to array-CGH analysis in order to detect gene copy number alterations such as gains/amplifications/deletions, and to next generation sequencing (NGS; MiSeq, Illumina) using a panel of ~400 genes for mutation detection.

NCT ID: NCT02261389 Active, not recruiting - Breast Cancer Clinical Trials

Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET

Start date: September 2014
Phase: N/A
Study type: Interventional

The main purpose of follow-up in asymptomatic breast cancer patients during and after adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local and distant recurrence compared to the usual follow-up practice.

NCT ID: NCT02252887 Active, not recruiting - Clinical trials for Metastatic HER2-Positive Breast Cancer

Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy

Start date: January 12, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if a combination of drugs can help to treat breast cancer. This is a Phase II study which will test whether this combination of drugs is effective and will provide further information on side effects and safety. A standard chemotherapy, gemcitabine, will be combined with 2 other drugs that target the HER2 receptor. The HER2 receptor is a growth protein on the surface of some breast cancer cells that provides messages telling the breast cancer cell to grow. The standard chemotherapy will be gemcitabine.. The other two drugs work against HER2. One is called trastuzumab (Herceptin) and it is commonly given to women with advanced and early HER2 positive breast cancer. The other drug, pertuzumab (Perjeta), is also given to women with advanced HER2 positive breast cancer. The drugs in this study are each individually approved for the treatment of metastatic breast cancer. However, this study is looking at the effectiveness of gemcitabine with trastuzumab and pertuzumab when given to women who have advanced HER2 positive breast cancer who have had prior trastuzumab + pertuzumab or pertuzumab-based therapy.

NCT ID: NCT02246621 Active, not recruiting - Breast Cancer Clinical Trials

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

MONARCH 3
Start date: November 6, 2014
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

NCT ID: NCT02240836 Active, not recruiting - Clinical trials for Stage II Breast Cancer

Energy Balance and Breast Cancer Aspects-II

EBBA-II
Start date: September 2014
Phase: N/A
Study type: Interventional

The purpose of this study, the EBBA-II trial, is to determine whether a 12 month exercise program comprised of strength and endurance training among newly diagnosed breast cancer patients undergoing adjuvant therapy, will influence cardiopulmonary function. Secondary aims are to determine whether the 12 month exercise program will influence factors associated with metabolic profile, tumor growth, disease-free survival, overall mortality and breast cancer specific mortality. Furthermore, the effect on QoL parameters, and dietary factors will be assessed and evaluated.

NCT ID: NCT02240472 Active, not recruiting - Breast Cancer Clinical Trials

Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.

Start date: January 27, 2015
Phase: N/A
Study type: Interventional

Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling. The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years. This study is a prospective international randomized trial including 3500 patients. Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival.

NCT ID: NCT02238808 Active, not recruiting - Clinical trials for Estrogen Receptor Positive Breast Cancer

A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers

PRESTO
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Some breast cancers have estrogen receptors (ER+). The investigators know that some ER+ tumours can be cured by hormone therapy alone while other ER+ breast cancers cannot. Currently, there is no perfect way to tell these groups apart nor do the investigators know why some respond when others do not. Research findings suggest that the two types of ER+ breast cancers differ in their response to estrogen with estrogen being toxic to one type and not the other. For those tumours that find estrogen toxic, this may explain why tumours only start to grow when estrogen levels decrease after menopause. The purpose of this study is to see whether a two-week treatment of estrogen equal to pre-menopausal estrogen levels will decrease the rate at which patients' ER+ tumours grow. This will be done by comparing the growth rate in the tissue removed during standard of care surgery after patients have been treated with 7-14 days of estrogen prior to that surgery.

NCT ID: NCT02237469 Active, not recruiting - Clinical trials for Breast Cancer Female

Prone Breast Radiotherapy Treatment Planning Observational Study

HUGProne
Start date: September 2010
Phase:
Study type: Observational

The study purpose is to evaluate whether or not clinical characteristics of women with breast cancer can predict which position for radiation treatment, prone or supine, will be associated with a dosimetry gain. Dosimetry gain in this study means the lowest radiation dose to non-target organs (heart, lungs, contralateral breast), while giving the prescribed dose to tumor bed and ipsilateral breast.

NCT ID: NCT02236806 Active, not recruiting - Breast Cancer Clinical Trials

Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab

SAFE
Start date: July 2015
Phase: Phase 3
Study type: Interventional

The aim of the study is to analyze the protective impact on the cardiac damage of beta blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based chemotherapy with or without trastuzumab.